FDA.reportPublic FDA data

DEXTRAGEL ANTISEPTIC HAND SANITIZER

Manufacturer
Dextra Gel, Llc
Effective date
2020-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:54

Label at a glance#

ProductDEXTRAGEL ANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store between 15-30°C (59-86˚F) avoid freezing and excessive heat above 40˚C (104˚F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86˚F)
  • avoid freezing and excessive heat above 40˚C (104˚F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, carbomer, triethanolamine, water

Questions? +1-888-385-4685

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

CONVENIENT EASY TO TEAR PACKETS

Clean Hands on the Go

A Simple Decision in an Uncertain World

Our convenient sanitizer packets provide the highest level of clean when soap and water are not within reach.

Each packet fits in the palm of your hand, providing a 2 mL measured amount. The easy tear packet allows for quick sanitizing and disposal for your valued customers, keeping them and their families safe.

Easy Tear Packs

Nontoxic

Distributed by: Dextragel LLC - Kennedale, TX 76060

Country of origin: China

www.dextragel.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80209-098-302022-01-28C16284748780-1d6a99b39-80fe-a426-e053-dadaa90af4c2DEXTRAGEL ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80209-098-30DEXTRAGEL ANTISEPTIC HAND SANITIZER50 in 1 BAGGEL501
80209-098-30DEXTRAGEL ANTISEPTIC HAND SANITIZER2 mL in 1 PACKETGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80209-098DEXTRAGEL ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [DEXTRA GEL, LLC]1Legacy NDC, 2 package rows20201211_0c4080b4-74aa-4151-a614-2e2dbd6e814e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80209-09880209-098-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ca678856-1e62-461c-bcdd-e56c00027e200c4080b4-74aa-4151-a614-2e2dbd6e814e2020-12-01WarningsExact identifier
spl id: ca678856-1e62-461c-bcdd-e56c00027e20
spl set id: 0c4080b4-74aa-4151-a614-2e2dbd6e814e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.